Fractyl Laboratories announced that the Company’s Revita DMRTM System, used to perform minimally invasive duodenal mucosal resurfacing for the treatment of metabolic diseases (Revita DMR procedure), has received European CE Mark approval. The announcement was made during a company presentation of new data in liver disease at the 2016 International Liver Conference of the European Association for the Study of Liver (EASL) in Barcelona, Spain. Fractyl’s presentation, “Endoscopic duodenal mucosal resurfacing (DMR) improves metabolic measures including hepatic transaminase levels in patients with type 2 diabetes (T2D): Data from a first-in-human study,” included new data that a single Revita DMR treatment improved metabolic control in patients with both type 2 diabetes and fatty liver disease. The results presented included a lowering of hepatic transaminase levels, sustained through six months of follow up.
“Both CE Mark approval and the first opportunity to share our early results in liver disease are major milestones for Fractyl and for our clinical and research partners. This is the first of several presentations on Revita DMR that will take place over the next two months across the major endocrinology, GI and diabetes conferences,” said Harith Rajagopalan, MD, PhD, Co-Founder and CEO of Fractyl.
CE Mark approval gives Fractyl the opportunity to commercialize Revita DMRTM in the European Union for the treatment of metabolic diseases such as type 2 diabetes and fatty liver disease. CE Marking confirms that Revita DMR has met the requirements of the European Medical Devices Directive.
In 2015, Fractyl announced results from 39 patients with poorly controlled type 2 diabetes in a single-site, proof-of-concept study in which beneficial changes in blood sugar were observed following Revita DMR. The data presented at EASL from the same population expands on this previously announced data and suggests beneficial changes in markers of fatty liver disease following Revita DMR.
“Both CE Mark approval and the first opportunity to share our early results in liver disease are major milestones for Fractyl and for our clinical and research partners. This is the first of several presentations on Revita DMR that will take place over the next two months across the major endocrinology, GI and diabetes conferences,” said Harith Rajagopalan, MD, PhD, Co-Founder and CEO of Fractyl.
CE Mark approval gives Fractyl the opportunity to commercialize Revita DMRTM in the European Union for the treatment of metabolic diseases such as type 2 diabetes and fatty liver disease. CE Marking confirms that Revita DMR has met the requirements of the European Medical Devices Directive.
In 2015, Fractyl announced results from 39 patients with poorly controlled type 2 diabetes in a single-site, proof-of-concept study in which beneficial changes in blood sugar were observed following Revita DMR. The data presented at EASL from the same population expands on this previously announced data and suggests beneficial changes in markers of fatty liver disease following Revita DMR.
a press release can be found from Fractyl Website by clicking here.
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